Brest CancerMONARCHE29NCT06621459
Retrospective Observational Study of the Safety and Toxicity Management of Abemaciclib in Combination with Adjuvant Hormone Therapy in Patients with RH+ ,HER2-nonoveramplified Breast Cancer, Real-life Data (MONARCHE29)
An observational study of Brest Cancer and Abemaciclib, run by University Hospital, Brest at 1 site in France.
Trial summary
Overall survival at 8 years under treatment for localized hormone-dependent breast cancer is 93.3% (1). Adjuvant therapy, especially hormone therapy, helps reduce the risk of recurrence. However, the risk of relapse remains significant, estimated at around 20% according to studies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brest Cancer, Abemaciclib, Adjuvant Therapy
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2024to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with high-risk RH+ HER2 non-amplified breast cancer according to the criteria of the MONARCH-E study, specifically: Either ≥ 4 pALN (positive axillary lymph nodes) Or 1-3 pALN and at least one of the following criteria: * Tumor size ≥ 5 cm * Or histological grade 3
Who may be able to join
- Adult patient
- Patient who has received adjuvant ABEMACICLIB in combination with hormone therapy
- Patient with localized RH+ HER2 non-amplified breast cancer and eligible for treatment with ABEMACICLIB according to the recommendations of the MA (Marketing Authorization) as defined below:
- 4 ipsilateral positive axillary lymph nodes OR
- to 3 ipsilateral positive axillary lymph node(s) with at least one of the following two criteria: histological grade 3 or primary tumor size ≥5 cm
Who cannot join
- Patients under legal protection (guardianship, trusteeship, etc.)
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Quentin LAUNE contact
France1 site, 1 recruiting
- Recruiting
Chu Brest
Brest, 29609
Quentin Laune, +33298223333, quentin.laune@chu-brest.fr
About this study
Official title: Retrospective Observational Study of the Safety and Toxicity Management of Abemaciclib in Combination with Adjuvant Hormone Therapy in Patients with RH+ ,HER2-nonoveramplified Breast Cancer, Real-life Data
Overall survival at 8 years under treatment for localized hormone-dependent breast cancer is 93.3% (1). Adjuvant therapy, especially hormone therapy, helps reduce the risk of recurrence.
However, the risk of relapse remains significant, estimated at around 20% according to studies. The SOFT study, which compares the type of hormone therapy used in premenopausal patients, estimates a relapse risk of 21.1% at 8 years (1), especially when there is initial lymph node involvement. In fact, in cases of lymph node involvement, the cumulative relapse rate at 10 years after stopping hormone therapy ranges between 19% and 36% (2), and the risk of death from breast cancer 20 years after stopping hormone therapy is estimated at 28% to 49% (2).
Read more
CDK4/6 inhibitors first demonstrated their efficacy at the metastatic stage. Abemaciclib improved median survival to 46.7 months compared to a median of 37.3 months with hormone therapy alone (Monarch 2 (3) and Monarch 3 (4)). Palbociclib showed in PALOMA-2 (5) an improvement in progression-free survival (24.8 months versus 14.5 months) without an improvement in overall survival. Ribociclib, in turn, demonstrated in MONALEESA 2 (6) an improvement in PFS (25.3 months versus 16 months) and in overall survival (63.9 months versus 51.4 months). These treatments have become the standard first-line treatment for patients with RH+ HER2 non-amplified breast cancer.
Given the results in advanced lines, CDK4/6 inhibitors have been the subject of studies in localized breast cancer, particularly in this high-risk population where the recurrence rate remains significant.
The MONARCH-E study, published on September 20, 2020 (7), led to the approval of Abemaciclib by European authorities at the time of the initial publication (median follow-up of 15.4 months) and to reimbursement starting in May 2023 after a second interim analysis (8) in this at-risk population, with a 5.6% reduction in relapse risk after 42 months of follow-up compared to hormone therapy alone.
It is crucial to clearly define the at-risk population in order to offer them treatment intensification while maintaining a satisfactory quality of life. The group benefiting from Abemaciclib presented grade III toxicity in 43% of cases and grade IV toxicity in 2.5%.
Real-world data are needed to better understand the management and toxicity of this treatment.
Read the detailed description
TARGET POPULATION
Patients with high-risk RH+ HER2 non-amplified breast cancer according to the criteria of the MONARCH-E study, specifically:
Either ≥ 4 pALN (positive axillary lymph nodes)
Or 1-3 pALN and at least one of the following criteria:
- Tumor size ≥ 5 cm
- Or histological grade 3 PRIMARY OBJECTIVE
Tolerance of treatment with ABEMACICLIB in combination with hormone therapy
SECONDARY OBJECTIVES
Recurrence-free survival Safety and tolerance of treatment with ABEMACICLIB Impact of dose reduction on treatment efficacy Incidence and management of digestive toxicity Incidence of hematological toxicity Incidence of pulmonary toxicity (with radiotherapy) Tolerance data in patients over 75 years Incidence and causes of permanent discontinuation of ABEMACICLIB Quality of life data
PRIMARY EVALUATION CRITERION
Dose intensity of ABEMACICLIB treatment at 6 months SECONDARY EVALUATION CRITERIA
Median duration of ABEMACICLIB treatment Cumulative dose of treatment Frequency and severity of side effects according to CTCAE V5 classification IDFS IDFS correlated with dose reduction METHODOLOGY Multicenter retrospective study based on data
STATISTICS For the demographic analysis of the study population, quantitative variables will be represented by their mean ± standard deviation or their median ± Q1-Q3 interval depending on their distribution. Qualitative variables will be represented by the number and proportion of individuals within each category.
If necessary, quantitative variables will be compared using the Student\'s t-test or the Wilcoxon test depending on their distribution. Qualitative variables will be compared using the Chi-square or Fisher test depending on their distribution.
INCLUSION CRITERIA
Adult patient Patient who has received adjuvant ABEMACICLIB in combination with hormone therapy
Patient with localized RH+ HER2 non-amplified breast cancer and eligible for treatment with ABEMACICLIB according to the recommendations of the MA (Marketing Authorization) as defined below:
≥4 ipsilateral positive axillary lymph nodes OR
1 to 3 ipsilateral positive axillary lymph node(s) with at least one of the following two criteria: histological grade 3 or primary tumor size ≥5 cm
EXCLUSION CRITERIA
Patients under legal protection (guardianship, trusteeship, etc.) Refusal to participate
NUMBER OF PATIENTS Cohort consisting of all patients meeting the inclusion criteria during the study period, approximately 30 patients.
TIMELINE Inclusion duration: 23 months
Data collection period (retrospective between May 2023 and June 2025):
Study completion time (i.e., sending non-objections + data entry): 25 months
FUNDING No funding
- Conditions
- Brest Cancer, Abemaciclib, Adjuvant Therapy, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms
- Keywords
- Abemaciclib, Adjuvant Therapy, Antineoplastic Combined Chemotherapy Protocols, Breast Cancer, Real-life, Real Word Data
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
the average dose of abemaciclib received over 6 months.
The primary criterion was the average dose of abemaciclib received over 6 months.
The average dose received was defined as: the dose administered per day, multiplied by the duration of treatment, taking into account periods of interruptions and dose reductions, divided by 183 days (6 months). This quantity can be expressed in mg/day or as a percentage of the maximum dose (full dose, without interruption).
This criterion will be used to divide the population into two groups. The threshold of two-thirds of the maximum dose was chosen, corresponding to the reduction of the first therapeutic adjustment step. It allows separation into a group receiving a so-called full dose, corresponding to two-thirds or more of the maximum dose, and a group receiving a reduced dose, corresponding to less than two-thirds of the maximum dose. This calculation allows the identification of patients who had at least one dose adjustment
Measured: over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start26 Sep 2024 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brest CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621459
- Sponsor's protocol ID
- 29BRC24.0244 - MONARCHE29
- Acronym
- MONARCHE29
- Status last verified
- Aug 2024
- First submitted
- 27 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observational Study of the Safety and Toxicity Management of Abemaciclib in Combination with Adjuvant Hormone Therapy in Patients with RH+ ,HER2-nonoveramplified Breast Cancer, Real-life Data
- ClinicalTrials.gov ID
- NCT06621459
- Acronym / sponsor ID
- MONARCHE29 / 29BRC24.0244 - MONARCHE29
- Conditions
- Brest Cancer, Abemaciclib, Adjuvant Therapy, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms
- Keywords
- Abemaciclib, Adjuvant Therapy, Antineoplastic Combined Chemotherapy Protocols, Breast Cancer, Real-life, Real Word Data
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 26 Sep 2024 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Overall survival at 8 years under treatment for localized hormone-dependent breast cancer is 93.3% (1). Adjuvant therapy, especially hormone therapy, helps reduce the risk of recurrence.
However, the risk of relapse remains significant, estimated at around 20% according to studies. The SOFT study, which compares the type of hormone therapy used in premenopausal patients, estimates a relapse risk of 21.1% at 8 years (1), especially when there is initial lymph node involvement. In fact, in cases of lymph node involvement, the cumulative relapse rate at 10 years after stopping hormone therapy ranges between 19% and 36% (2), and the risk of death from breast cancer 20 years after stopping hormone therapy is estimated at 28% to 49% (2).
CDK4/6 inhibitors first demonstrated their efficacy at the metastatic stage. Abemaciclib improved median survival to 46.7 months compared to a median of 37.3 months with hormone therapy alone (Monarch 2 (3) and Monarch 3 (4)). Palbociclib showed in PALOMA-2 (5) an improvement in progression-free survival (24.8 months versus 14.5 months) without an improvement in overall survival. Ribociclib, in turn, demonstrated in MONALEESA 2 (6) an improvement in PFS (25.3 months versus 16 months) and in overall survival (63.9 months versus 51.4 months). These treatments have become the standard first-line treatment for patients with RH+ HER2 non-amplified breast cancer.
Given the results in advanced lines, CDK4/6 inhibitors have been the subject of studies in localized breast cancer, particularly in this high-risk population where the recurrence rate remains significant.
The MONARCH-E study, published on September 20, 2020 (7), led to the approval of Abemaciclib by European authorities at the time of the initial publication (median follow-up of 15.4 months) and to reimbursement starting in May 2023 after a second interim analysis (8) in this at-risk population, with a 5.6% reduction in relapse risk after 42 months of follow-up compared to hormone therapy alone.
It is crucial to clearly define the at-risk population in order to offer them treatment intensification while maintaining a satisfactory quality of life. The group benefiting from Abemaciclib presented grade III toxicity in 43% of cases and grade IV toxicity in 2.5%.
Real-world data are needed to better understand the management and toxicity of this treatment.
Detailed description
TARGET POPULATION
Patients with high-risk RH+ HER2 non-amplified breast cancer according to the criteria of the MONARCH-E study, specifically:
Either ≥ 4 pALN (positive axillary lymph nodes)
Or 1-3 pALN and at least one of the following criteria:
- Tumor size ≥ 5 cm
- Or histological grade 3 PRIMARY OBJECTIVE
Tolerance of treatment with ABEMACICLIB in combination with hormone therapy
SECONDARY OBJECTIVES
Recurrence-free survival Safety and tolerance of treatment with ABEMACICLIB Impact of dose reduction on treatment efficacy Incidence and management of digestive toxicity Incidence of hematological toxicity Incidence of pulmonary toxicity (with radiotherapy) Tolerance data in patients over 75 years Incidence and causes of permanent discontinuation of ABEMACICLIB Quality of life data
PRIMARY EVALUATION CRITERION
Dose intensity of ABEMACICLIB treatment at 6 months SECONDARY EVALUATION CRITERIA
Median duration of ABEMACICLIB treatment Cumulative dose of treatment Frequency and severity of side effects according to CTCAE V5 classification IDFS IDFS correlated with dose reduction METHODOLOGY Multicenter retrospective study based on data
STATISTICS For the demographic analysis of the study population, quantitative variables will be represented by their mean ± standard deviation or their median ± Q1-Q3 interval depending on their distribution. Qualitative variables will be represented by the number and proportion of individuals within each category.
If necessary, quantitative variables will be compared using the Student\'s t-test or the Wilcoxon test depending on their distribution. Qualitative variables will be compared using the Chi-square or Fisher test depending on their distribution.
INCLUSION CRITERIA
Adult patient Patient who has received adjuvant ABEMACICLIB in combination with hormone therapy
Patient with localized RH+ HER2 non-amplified breast cancer and eligible for treatment with ABEMACICLIB according to the recommendations of the MA (Marketing Authorization) as defined below:
≥4 ipsilateral positive axillary lymph nodes OR
1 to 3 ipsilateral positive axillary lymph node(s) with at least one of the following two criteria: histological grade 3 or primary tumor size ≥5 cm
EXCLUSION CRITERIA
Patients under legal protection (guardianship, trusteeship, etc.) Refusal to participate
NUMBER OF PATIENTS Cohort consisting of all patients meeting the inclusion criteria during the study period, approximately 30 patients.
TIMELINE Inclusion duration: 23 months
Data collection period (retrospective between May 2023 and June 2025):
Study completion time (i.e., sending non-objections + data entry): 25 months
FUNDING No funding
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with high-risk RH+ HER2 non-amplified breast cancer according to the criteria of the MONARCH-E study, specifically: Either ≥ 4 pALN (positive axillary lymph nodes) Or 1-3 pALN and at least one of the following criteria: * Tumor size ≥ 5 cm * Or histological grade 3
Key inclusion criteria (5 listed)
- Adult patient
- Patient who has received adjuvant ABEMACICLIB in combination with hormone therapy
- Patient with localized RH+ HER2 non-amplified breast cancer and eligible for treatment with ABEMACICLIB according to the recommendations of the MA (Marketing Authorization) as defined below:
Key exclusion criteria (2 listed)
- Patients under legal protection (guardianship, trusteeship, etc.)
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the average dose of abemaciclib received over 6 months.
Time frame: over 6 months
The primary criterion was the average dose of abemaciclib received over 6 months. The average dose received was defined as: the dose administered per day, multiplied by the duration of treatment, taking into account periods of interruptions and dose reductions, divided by 183 days (6 months). This quantity can be expressed in mg/day or as a percentage of the maximum dose (full dose, without interruption). This criterion will be used to divide the population into two groups. The threshold of two-thirds of the maximum dose was chosen, corresponding to the reduction of the first therapeutic adjustment step. It allows separation into a group receiving a so-called full dose, corresponding to two-thirds or more of the maximum dose, and a group receiving a reduced dose, corresponding to less than two-thirds of the maximum dose. This calculation allows the identification of patients who had at least one dose adjustment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Brest Cancer
Not yet recruitingPhase 2
De-EscaLaTion of Aromatase Inhibitor Therapy: A Randomized Phase II Study of De-escalated Letrozole in Hormone Receptor-Positive Early Breast Cancer
Brest Cancer ER+ and HER2 Negative
Active, not recruiting
Creation and Implementation a Method for Breast Reconstruction After Radical Surgery Using Decellularized Xenomatrix in Combination With Lymphovenous Anastomosis in Breast Cancer.
Brest Cancer
Recruiting
Topical Diclofenac for Prevention of Radiation-induced Dermatitis
Head and Neck Tumor, Breast Cancer
Active, not recruitingObservational study
Effectiveness and Safety of Palbociclib: Brand vs. Generic in Iraqi Stage IV Breast Cancer Patients
Brest Cancer, CDK4/6 Inhibitor
Not yet recruitingObservational study
Wide-Angle Tomosynthesis and AI in Diagnostic Mammography
Breast Neoplasms Diagnosis, Brest Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quentin LAUNE contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brest Cancer and Abemaciclib, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanuelle RENAUD (0298223396 ext. +33, emmanuelle.renaud@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the average dose of abemaciclib received over 6 months. (time frame: over 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.